The READ-2 Study: Ranibizumab for Edema of the mAcula in Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Genentech
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00407381
First received: December 1, 2006
Last updated: January 30, 2009
Last verified: January 2009

December 1, 2006
January 30, 2009
December 2006
December 2008   (final data collection date for primary outcome measure)
Improvement in vision of 15 or more letters, or achieve a final vision of 50 letters (20/25) or better if baseline VA was 40 letters (20/40) [ Time Frame: 6 mos, 12 mos and 24 mos. Study Extended to 36 mos. ] [ Designated as safety issue: Yes ]
Improvement in vision of 15 or more letters, or achieve a final vision of 50 letters (20/25) or better if baseline VA was 40 letters (20/40)
Complete list of historical versions of study NCT00407381 on ClinicalTrials.gov Archive Site
Several outcomes related to OCT measurements and fluorescein angiography. [ Time Frame: 6 mos, 12 mos and 24 mos, study extended to 36 mos. ] [ Designated as safety issue: Yes ]
Several outcomes related to OCT measurements and fluorescein angiography.
Not Provided
Not Provided
 
The READ-2 Study: Ranibizumab for Edema of the mAcula in Diabetes
Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study)

This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME.

RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.

The READ-2 Study is a phase 2 randomized, multi-center clinical trial to be conducted under an investigator-initiated IND. The study aims to enroll 126 patients, who will be randomized into 3 different groups. The primary objectives of the READ-2 Study are: (a) to obtain data on the bioactivity and dose interval effects of intravitreal ranibizumab (RBZ) alone, as well as in combination with laser photocoagulation, on retinal thickness and visual acuity in subjects with DME; and (b) to obtain additional safety and bioactivity data to aid in the design of a phase 3 clinical trial to evaluate ranibizumab as a therapeutic option for patients with DME The study consists of a 2-week screening period (Days -14 to 0), a 6-month treatment period with a primary time endpoint, and a 18-month follow-up and treatment period with secondary time endpoints. Consented subjects will enter the 14-day screening period to determine eligibility. Serum chemistry and hematology testing, urinalysis, pregnancy testing, and macular thickness measurements based on optical coherence tomography (OCT) will be performed. Screening will also include VA, ophthalmic examination and FA entry criteria.

Patients who have ETDRS visual acuity of 20/40 or worse, but better than or equal to 20/320 due to foveal thickening from macular edema secondary to diabetes (type 1 or 2) and who meet eligibility criteria will be eligible to enroll in the study. Baseline foveal thickness by OCT must be at least 250, which is often associated with VA of 20/40 or worse and which provides sufficient thickening so that a treatment effect is easily detectable (Nguyen et al. 2004). Approximately 126 patients with DME will be enrolled in this study from all clinical sites in the study. Every effort will be made to recruit and enroll eligible patients from men and women of all ethnic and social backgrounds. Patients who meet entry criteria will be able to enroll in the study until the quota of patients has been achieved.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
  • Drug: Ranibizumab
    Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
  • Procedure: Laser photocoagulation
    Laser photocoagulation in either focal or grid pattern as determined by investigator.
  • Experimental: RBZ
    RBZ intravitreal injection alone
    Intervention: Drug: Ranibizumab
  • Active Comparator: Laser
    Laser photocoagulation
    Intervention: Procedure: Laser photocoagulation
  • Experimental: Laser with RBZ
    Laser following intravitreal injection of RBZ
    Interventions:
    • Drug: Ranibizumab
    • Procedure: Laser photocoagulation
Do DV, Nguyen QD, Khwaja AA, Channa R, Sepah YJ, Sophie R, Hafiz G, Campochiaro PA; READ-2 Study Group. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmol. 2013 Feb;131(2):139-45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
126
December 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion:

  • Signed informed consent and authorization of use and disclosure of protected health information
  • Age greater than 18 years
  • Diagnosis of diabetes mellitus (type 1 or type 2) and serum HbA1c greater than 5.5% within 12 months of randomization
  • Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea.
  • Diagnosis must be confirmed by OCT images
  • Foveal thickness of greter than 250, as assessed by OCT
  • Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be greater than 20/800.
  • In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes.
  • In the opinion of the investigator, laser photocoagulation can be withheld for at least 30 days after the patient has enrolled in the study

Exclusion Criteria:

  • Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
  • Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
  • Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
  • Eyes in which the investigators do not feel appropriate to do any additional laser photocoagulation
  • Proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation or tufts of NVE less than one disc area with no vitreous hemorrhage
  • Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
  • Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
  • Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)
  • Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period
  • Eyes which are likely to need cataract surgery and intraocular lens implantation within the first 6 months of the study
  • Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 2 months of study entry; or any other intraocular surgery within 3 months preceding Day 0.
  • History of vitreoretinal surgery in the study eye within 3 months of study entry
  • Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite treatment with anti-glaucoma medications)
  • Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value greater than 12%
  • Premenopausal women not using adequate contraception
  • Any women who are pregnant
  • INR greater than or equal to 3.0 (e.g. due to current treatment with warfarin). The use of aspirin or other anticoagulants is not an exclusion
  • History of gastrointestinal bleeding within 2 months of study enrollment
  • History of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment
  • Any patients who are on renal dialysis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407381
NA_00005254
Yes
Quan Dong Nguyen, MD, MSc, Johns Hopkins University
Johns Hopkins University
  • Juvenile Diabetes Research Foundation
  • Genentech
Principal Investigator: Diana Do, MD Johns Hopkins Universtiy
Johns Hopkins University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP